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Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

FDA Recall #Z-2138-2025 — Class II — June 18, 2025

Recall #Z-2138-2025 Date: June 18, 2025 Classification: Class II Status: Ongoing

Product Description

Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

Reason for Recall

Natus received two complaints of left side labeling show impedance for right side.

Recalling Firm

Natus Neurology DBA Excel Tech., Ltd. (XLTEK) — Oakville, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

27 units

Distribution

US: CA, IN, MO, NC, PA, RI, TX

Code Information

UDI/DI 038283NA00153ED, Serial Numbers: 021918100008-M, 021918100014-M, 021918100015-M, 021918100017-M, 021918100019-M, 021918100020-M, 021918100021-M, 021918100025-M, 021918100026-M, 021918100028-M, 021918100032-M, 021918100034-M, 021918100036-M, 021918100038-M, 021918100039-M, 021918100040-M, 021918100041-M, 021918100044-M, 021918100046-M, 021918100047-M, 021918100048-M, 021918100049-M, 021918100050-M, 021918100051-M, 021918100052-M, 021918100054-M, 021918100055-M.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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